Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	11/2/2018
Start Date:	March 21, 2016
End Date:	July 29, 2016

Tocilizumab Real-Life Human Factors Validation Study

This study is designed to evaluate RLHFs concerning administration of the tocilizumab
autoinjector AI-1000 G2 in adults with rheumatoid arthritis (RA) who have been receiving
subcutaneous (SC) tocilizumab using the commercially available prefilled syringe and needle
safety device (PFS-NSD). The study will enroll participants with RA, a subset of whom will be
assigned to perform self-injection with the AI-1000 G2. Enrolled caregivers (CGs) and
healthcare professionals (HCPs) will administer the AI-1000 G2 injection to the remaining
study participants.

Inclusion Criteria:

- Participants with RA for greater than or equal to (>/=6) months receiving 162 mg
tocilizumab PFS-NSD for >/=8 weeks and who are suitable for continued treatment at
their currently prescribed dose

- CGs and professionally qualified HCPs who are able and willing to administer the
injection

Exclusion Criteria:

- RA: Functional status Class IV

- RA: Neuropathies or other conditions that might interfere with pain evaluation

- RA: Pregnant or breastfeeding

- RA: Low neutrophil or platelet count at last laboratory assessment

- RA: Elevated liver enzymes at last laboratory assessment

- Current participation in another interventional clinical trial

- Criteria that might give the participant/CG/HCP an advantage in injection tasks such
as employment in the pharmaceutical industry, etc.

We found this trial at

sites

Bluegrass Comm Research, Inc.

470 Cooper Drive
Lexington, Kentucky 40515

from

Lexington, KY